On December 14, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported an expansion of the pipeline with a potential first-in-class preclinical oncology vaccine program aimed at preventing and treating colorectal cancer (Press release, Nykode Therapeutics, DEC 14, 2023, View Source [SID1234638571]).

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Colorectal cancer begins as a premalignant polyp that grows on the mucosal surface of the colon or rectum and transforms into malignancy. The disease development and screening programs represent an opportunity to identify and treat high-risk patients at early stages in addition to treating patients with developed malignancies.

Nykode’s novel vaccines are based on a careful selection and combination of highly expressed tumor associated antigens involved in the development and progression of colonic polyps to colorectal cancer. The program will incorporate Nykode’s 4th module proprietary second-generation technology to further optimize the immune responses tailored to diverse target populations. The program builds on Nykode’s differentiating competence of creating broad and robust CD8 T cell responses with the potential to break tolerance against tumor-associated antigens, as illustrated by data presented at Nykode’s recent Capital Market Day. Strong preclinical data generated in the discovery phase further supports the induction of potent CD8 T cell responses in both wild-type and HLA transgenic mice models.

"I am thrilled about this exciting addition to our pipeline, which underscores Nykode’s dedication to creating innovative solutions for an expanding range of patients in need of alternative therapies," said Mikkel W. Pedersen, Nykode’s Chief Scientific Officer.

"Additionally, it signifies our belief in the promise of cancer vaccines across all stages of cancer development." "The potential first-in-class program reaffirms Nykode’s vision of building a balanced cancer vaccine portfolio. We are excited about the transformative power of our next-generation technology with the potential to reduce the burden of colorectal cancer," commented Michael Engsig, CEO of Nykode.

On December 14, 2023 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported an update on its clinical pipeline (Press release, NextCure, DEC 14, 2023, View Source [SID1234638570]).

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NC410 (LAIR-2 fusion)

● The Phase 1b combination trial of NC410 with pembrolizumab is ongoing.
● Given evidence of clinical activity to date, additional patients are being added to the 100 mg cohort of patients with microsatellite stable/microsatellite instable-low immune checkpoint inhibitor naïve colorectal cancer without active liver metastasis.
● The combination has been safe and well tolerated to date.
● Clinical data, including results from additional patients, are expected in the first half of 2024.

LNCB74 (B7-H4 ADC) and NC762 (B7-H4 mAb)

● Due to the competitive environment and the limited activity to date, we do not plan to further develop NC762. We are prioritizing the development of LNCB74 (B7-H4 ADC), the first antibody drug conjugate (ADC) candidate from our collaboration with LegoChem Biosciences, Inc., and shifting resources from NC762 to the ADC program.
● Based on a comprehensive preclinical data package, we plan to initiate a dose range-finding toxicology study and GMP manufacturing for LNCB74 in early 2024.

NC525 (LAIR-1 mAb)

● The Phase 1a dose escalation study in subjects with acute myeloid leukemia remains ongoing with the fourth cohort now enrolled.
● Safe and well tolerated to date.
● Clinical data are expected in the first half of 2024.
● Data defining the mechanism of action were published in Journal of Clinical Investigation in November.

Business Development

● Actively seeking strategic partners to accelerate global development of programs.

On December 14, 2023 Nerviano Medical Sciences S.r.l. (NMS), a clinical-stage biotechnology company member of NMS group, reported the signing of a license agreement with Italfarmaco S.p.A. (ITF), a specialty pharmaceutical company, to develop and commercialize a novel peptide-drug conjugate (PDC) (Press release, Nerviano Medical Sciences, DEC 14, 2023, View Source [SID1234638569]).

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Under the terms of the agreement, ITF will use NMS’s proprietary linker-payload technology to develop a novel PDC product candidate. NMS has implemented linker-payload GMP manufacturing and supply at a CDMO referred by NMS. ITF will be responsible for generating the target peptide and all non-clinical, clinical, and commercialization activities related to any resulting proprietary product candidates. Financial details of the agreement have not been disclosed.

"NMS’s cutting-edge linker-payload technology will allow us to develop new peptide drug conjugates for the treatment of oncology indications with high unmet medical need, leveraging Italfarmaco’s state-of-the-art GMP peptide production capabilities," stated Christian Steinkühler, PhD, Italfarmaco Group’s Chief Scientific Officer. "This is an important milestone in our mission to generate a highly diversified pipeline of innovative medicines."

"We are pleased that ITF, a company with a long-standing heritage both from pharmaceutical and chemical sectors, has selected our linker-payload first platform for developing a truly novel peptide-drug conjugate. This is a significant step to broaden the applicability of our technology," said Hugues Dolgos, PharmD, Chief Executive Officer of NMS and NMS Group.

On December 14, 2023 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company"), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reported that the first patient has initiated treatment at the Beverly Hills Cancer Center (BHCC) in the Company’s Deltacel-01 clinical trial (Press release, Kiromic, DEC 14, 2023, View Source [SID1234638567]). This Phase 1 study is evaluating Deltacel for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC).

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Initial tolerability and safety data from this first patient is expected to be available by year-end. Additionally, Kiromic expects to report preliminary efficacy results from the first patient by the end of January 2024.

The Company expects that the Deltacel-01 clinical trial will start enrolling patients at two additional clinical sites in early 2024.

"We are extremely proud to initiate this first-in-human trial of Deltacel when we stated we would," said Pietro Bersani, Chief Executive Officer of Kiromic. "Non-small cell lung cancer represents a significant unmet medical need, and a leading cause of death in the U.S. We look forward to enrolling additional patients to advance the clinical development of Deltacel for the treatment of solid tumors, starting with NSCLC."

"Beverly Hills Cancer Center is pleased to announce the dosing of the first patient in our Deltacel-01 study," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. "We are excited about the potential of this novel Gamma Delta T-cell therapy combined with low dose radiation for our patients with lung cancer who have few treatment options left. We look forward to evaluating long term safety and efficacy outcomes as the study progresses."

Dr. Arash Gabayan, Radiation Oncologist at Beverly Hills Cancer Center and the sub-investigator who administered the low dose radiation treatments, commented: "The first course of combination of Deltacel and low dose radiation was successfully delivered to this first patient. Our clinical research team will continue monitoring this patient closely as we seek to understand how this innovative and exciting dual approach may impact the immune response against the cancer cells. We are hopeful that this investigational treatment approach can make a meaningful difference for lung cancer patients."

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary ones include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of non–small cell lung cancer. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is Kiromic BioPharma’s leading candidate in its GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On December 14, 2023 The European Organisation for Research and Treatment of Cancer (EORTC) reported the launch of EORTC 2120 RAVINA trial supported by the EORTC Head and Neck Cancer Group and by Merck entitled "Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study" (Press release, EORTC, DEC 14, 2023, View Source [SID1234638563]).

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This randomised, placebo-controlled, phase II study will determine the efficacy and safety of xevinapant with radiotherapy in older patients. Patients aged 70 years or older with LA-HNSCC of oral cavity, oropharynx, hypopharynx, or larynx for which treatment with radiotherapy only is recommended will be enrolled in the study.

This study aims to find out whether the addition of xevinapant increases response to radiotherapy, progression free survival and overall survival and may impact health-related quality of life, frailty and circulating markers.

Launch of the trial across Europe

Ten countries have been selected to participate in the trial (Italy, France, Belgium, Spain, Ireland, Germany, the Netherlands, Slovenia, Norway and the United Kingdom) with 27 sites expected to enrol approximately 230 patients.

Merck will provide xevinapant and the placebo. The study was submitted under the new EU Clinical Trial Regulation in March 2023. Today, 7 sites have been authorised in five countries. First Patient In has been enrolled in Belgium.

Xevinapant (formerly known as Debio 1143) is an investigational, orally taken Inhibitor of Apoptosis Protein (IAP) inhibitor that may promote cancer cell death via apoptosis. Xevinapant is believed to sensitize tumour cells for various cytotoxic therapies, including radiotherapy and chemotherapy.

Improving progression-free survival with limited toxicity in older patients

"Locally advanced head and neck cancer is a debilitating disease that is increasingly diagnosed in older patients. These patients often do not tolerate or benefit from addition of chemotherapy to radiotherapy and are therefore treated with radiotherapy alone. The disease relapses in more than half of the patients. An earlier study showed that xevinapant added to chemoradiotherapy reduced relapses and improved overall survival with limited extra toxicity. We therefore hypothesize that xevinapant will also improve efficacy of radiotherapy alone" said Dr. Sjoukje Oosting, Medical Oncologist at the University Medical Centre in Groningen, the Netherlands, lead investigator of the EORTC 2120 RAVINA study.